Directive 2007/47/EC

Revision of the European Medical Device Regulation

Course Objectives

• Identify the new or amended requirements or changed requirements from the revision of directives 90/385/EEC and 93/42/EEC
• Identify and analyze the impact of this regulatory revision for demonstrating compliance of medical devices:
  • Classification
  • Quality System
  • Technical documentation
  • Collection and evaluation of clinical data
• Understand how to transition
• Understand the evolution of roles of regulatory actors (competent authorities and notified bodies)

Learn More

To get a detailed curriculum, find out scheduled locations or request this program in your area, contact LNE/G-MED America.

For an economical way to train multiple staff, ask us about an on-site program at your company.